A Phase 2 interventional study of Mirtazapine and Olanzapine in Anorexia Nervosa with Significantly Low Body Weight, sponsored by Englewood Hospital and Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Englewood Hospital and Medical Center · Phase 2, Interventional, and Treatment
Among 173 studies in Anorexia Nervosa with a site in United States — 36 open to participants now, 45 under way, none of them phase 3. Anorexia Nervosa · United States.
Among the 173 studies in Anorexia Nervosa with a site in United States, this one is the 9th largest by planned enrollment of the 142 interventional ones, is one of 16 that started in 2022, is one of 20 in phase 2, reaches primary completion later than 11 of the 44 other live ones, and was the 118th registered.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 170 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →36 of the 173 studies in Anorexia Nervosa with a site in United States are open now, in 6 countries. Each count lists the studies.
Of the 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →173 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 16 started in 2022.
Median enrollment 40 across the 142 interventional studies, 66 across the 31 observational. Of the 122 that completed or were terminated, 34 (28%) have results posted.
4 of 173 have an industry lead sponsor. The 10 most frequent:
Englewood Hospital and Medical Center is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Englewood Hospital and Medical Center has 1 study filed under Anorexia Nervosa — fewer than ten, so there is no comparison to draw.
20 of the studies in Anorexia Nervosa with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532734Denver Health and Hospital AuthorityBarrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype | 2026-11 |
| NCT05509257Children's Mercy Hospital Kansas CityNaltrexone Neuroimaging in Teens With Eating Disorders | 2026-12 |
| NCT04583774University of California, San DiegoDeveloping an EEG Paradigm to Study Prediction Error in Anorexia Nervosa | 2026-12 |
| NCT05197309Icahn School of Medicine at Mount SinaiMetabolic Diet for Relapse Prevention in Anorexia Nervosa | 2026-12 |
| NCT05170919Englewood Hospital and Medical CenterComparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer | 2026-12 |
Among the 173 studies in Anorexia Nervosa with a site in United States, from their registry updates:
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
18 years of age or older
At any point of treatment with standard chemotherapy*
o Scheduled to start, have discontinued or completed, or currently receiving
Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation
o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).
Able to communicate well and comply with study requirements, including by phone and written logs
Exclusion Criteria:
Abnormal liver function defined as > twice
Elevated
o performed within 1 year of enrollment will be accepted
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Olanzapine
Drug: Mirtazapine
Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated.
the participant will be prescribed a dosage of 2.5mg per day if \> 65 yrs. and 5 mg/per day if \<65 yrs. per day. Per physician discretion, participants are allowed a dose escalation of a maximum of 10mg.
Weight
Patients will have their weight measured every month. A ratio of 5% weight gain or weight stabilization over time will be used to determine if the medication is making an impact.
Time frame: 6 months
Quality of Life of patient
Patients will complete a quality of life (QOL) questionnaire provided at each time point. The higher the score, the worse the outcome. Patients will rate their improvement on a scale from 0 to 4.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2026, 59 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Mirtazapine · Olanzapine
Englewood Hospital and Medical Center